Brief Title
Prospective Study Looking at Quality of Life Measures in Non-ischaemic Cardiomyopathy After Mitral Valve Repair
Official Title
Quality of Life Measures After Mitral Valve Repair in Non-Ischaemic Cardiomyopathy
Brief Summary
- Chronic severe mitral regurgitation can lead to symptoms and left ventricular
dysfunction.
- The purpose of this study is to prospectively follow patients with non-ischaemic
cardiomyopathy who are eligible for mitral valve repair surgery and primarily measure
the quality of life through the Minnesota Living with Heart Failure Questionnaire & the
Kansas City Cardiomyopathy Questionnaire.
Detailed Description
- Chronic mitral regurgitation (MR) usually spirals into a vicious cycle of left
ventricular (LV) volume overload, LV dilatation, mitral annular dilatation and more MR.
"MR begets MR". Eventually symptoms and LV dysfunction ensue. However, it can often be
treated medically or surgically. Medical therapy is primarily afterload reduction and
diuretics. Surgically, there are two options, either mitral valve repair or replacement.
- A number of retrospective studies have demonstrated improved LV function and survival in
patients undergoing valve repair compared to valve replacement with or without
subvalvular preservation. In one report, for example, patients who underwent valve
repair were compared to patients who underwent valve replacement. The report found that
the former group had lower operative mortality, a greater increase in LV ejection
fraction and higher overall ten year survival.
- The bulk of the literature at present addresses left ventricular dimensions, ejection
fraction, geometry and New York Heart Association functional class, but few have
addressed quality of life measures. In addition, most of these studies were
retrospective and the majority of patients had concomitant ischaemic heart disease.
- Even though the studies concerning quality of life after mitral valve surgery have been
few, nevertheless, some have addressed isolated valve surgery without concomitant bypass
surgery and have shown improved quality of life, though follow up in some was limited to
3 months. We will follow our population for 12 months after surgical repair.
- We will primarily look at subjective measures for quality of life such as the Minnesota
Living with Heart Failure Questionnaire & the Kansas City Cardiomyopathy Questionnaire,
as subjective measures are becoming more and more important following cardiac surgery.
Patients will serve as their own controls and all study parameters will be compared pre-
and post surgery.
Study Type
Observational
Primary Outcome
Quality of Life scores as measured by the Minnesota Living with Heart Failure Questionnaire & the Kansas City Cardiomyopathy Questionnaire
Secondary Outcome
1- Echocardiographic parameters 2- 6 minute walk test 3- NYHA class 4- Hospitalisation for heart failure, redo surgery, morbidity & mortality
Condition
Mitral Valve Insufficiency
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
20
Start Date
December 2007
Completion Date
June 2009
Eligibility Criteria
Inclusion Criteria:
- Patients that fulfill surgical criteria set by the 2006 ACC/AHA guidelines for the
management of patients with valvular heart disease.
- Symptomatic mitral regurgitation with left ventricular dysfunction (LVEF < or = 40%)
on maximal medical therapy
Exclusion Criteria:
- Mitral valve replacement
- Concomitant coronary artery bypass surgery
- Patient unable to give informed consent
Gender
All
Ages
21 Years - 80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Nadia Giannetti, MD.,FRCPC, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00483236
Organization ID
BMB-06-022
Study Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Sponsor
Nadia Giannetti, MD.,FRCPC, Principal Investigator, Director of Heart Failure and Transplant Centre at McGill University Health Centre
Verification Date
September 2009